RecruitingNCT01420562
Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
55 participants
Start Date
Sep 1, 2011
Study Type
OBSERVATIONAL
Conditions
Summary
The goal of this study is to calculate pharmacokinetic parameters and to evaluate the trough levels of posaconazole reached in patients with different stages of mucositis, due to chemotherapy and total body irradiation.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria1
- Patients receiving allogeneic stem cell transplantation - Treated with prophylactic posaconazole: oral suspension (200mg three times daily) or tablet (300mg once daily) to prevent invasive fungal infections
Exclusion Criteria4
- Gastroparesis
- Vomiting or diarrhea within 2 hours after intake of posaconazole
- Concomitant administration of potent inducers of the enzyme UGT1A4: carbamazepine,phenytoin, phenobarbital, rifabutin, rifampicin,...
- Age under 18 years
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Interventions
PROCEDUREblood sampling
During posaconazole treatment, blood sampling will occur on day 0 (=day of transplantation), day 7 and 14 to correlate posaconazole exposure to severity of mucositis.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT01420562
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